Vishal Kanani
Regulatory Affairs Leader, Digital Health
- Role
- Sr Manager, Regulatory Affairs at iRhythm Technologies, Inc.
- Location
- Menlo Park, CA, US
- LinkedIn followers
- 500 followers
About Vishal Kanani
Regulatory Affairs Certified (RAC-US) professional specializing in digital health and AI/ML-enabled medical devices, with expertise in FDA pathways for Software as a Medical Device (SaMD), AI-driven diagnostics, cybersecurity, and human factors. I bring international regulatory experience, including strategies for CE marking in EU countries, UK MHRA approvals, and Japan PMDA submissions, ensuring global market access alongside compliant premarket and postmarket compliance. Experienced in leading regulatory affairs teams, I excel at translating complex technical challenges into clear, actionable plans that drive alignment and success. Passionate about advancing data-driven healthcare through forward-thinking regulation.
Experience
Sr Manager, Regulatory Affairs
Aug 2024 — Present · San Francisco, CA, US
Education
University of Southern California
Masters
2009 — 2011
University of Mumbai
Bachelor
2005 — 2009
Skills
- Regulatory Affairs
- Validation
- V
- Quality Assurance
- Pma
- Corrective and Preventive Action (Capa)
- Regulatory Requirements
- Regulatory Submissions
- Protocol
- Medical Devices
- Clinical Research
- Capa
- U.s. Food and Drug Administration (Fda)
- Quality Control
- Gmp
- Quality System
- Iso 13485
- Pharmaceutical Industry
- Fda
- Irb
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